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FDA 510(k)

AVENTIX PFX 系统 (PFX01)；NOVOCLEAR 设备 (CLR001)

K号: K260255 · 2026-03-27

申请人Aventix Medical, Inc.
决定日期2026-03-27
产品代码GEI
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决定实质等同

器械摘要

AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001) is the device name listed in this FDA 510(k) record. The listed applicant is Aventix Medical, Inc.. It received FDA 510(k) clearance on 2026-03-27 under 510(k) number K260255. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001)?

AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001) is a medical device that received FDA 510(k) clearance on 2026-03-27. The listed applicant is Aventix Medical, Inc.. The 510(k) number is K260255.

When did AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001) receive FDA 510(k) clearance?

AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001) received FDA 510(k) clearance on 2026-03-27, under 510(k) number K260255.

Who is the listed applicant for AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001)?

The FDA 510(k) record lists Aventix Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001)?

The FDA product code for AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001) is GEI.

相关临床试验

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

相关器械（代码：GEI）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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官方来源

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